(144 days)
C. albicans PNA FISH is a fluorescence qualitative nucleic acid hybridization assay intended for identification of Candida albicans on smears made from yeast positive blood cultures.
Subculturing of yeast positive blood cultures is necessary to recover organisms for susceptibility testing and/or differentiation of mixed growth.
C. albicans PNA FISH is indicated for use as an aid in the diagnosis of C. albicans fungemia.
Not Found
This document is a marketing authorization from the FDA for a device called "C. albicans PNA FISH™". It is a letter confirming the device's substantial equivalence to previously marketed devices. However, the letter itself does not contain the detailed study information, acceptance criteria, or performance data requested in the prompt. This type of information is typically found in the 510(k) summary or the full submission.
Therefore, I cannot fulfill the request using only the provided text. The document primarily focuses on regulatory approval and classification, not the detailed scientific evidence supporting the device's performance.
§ 866.2660 Microorganism differentiation and identification device.
(a)
Identification. A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.